NCT04909606 Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
| NCT ID | NCT04909606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Long Term Corticosteroid Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 191 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2028-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 191 participants in total. It began in 2022-04-26 with a primary completion date of 2028-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Long term corticosteroid therapy concerns 0.5 to 1% of the population and about 2.5% of elderly subjects. It is currently used as a cornerstone therapy in a wide variety of clinical contexts. The central problematic of prolonged corticosteroid therapy is the burden of adverse events associated with its long term use, including bone, metabolic and infectious complications. The management of patients for whom the prescription of long term corticosteroid therapy is indicated should include an evaluation of the individual risk and implementation of the appropriate preventive measures. Such an approach should particularly include cortisonic osteoporosis prevention, infectious prevention including vaccination, prevention of adrenal insufficiency, promotion of physical activity, as well as dietary management. In France, nurse-led prevention programs are highly developed for patients initiating immunosuppressive targeted therapies. Conversely, there are no dedicated nurse-led programs for patients starting prolonged corticosteroid therapy, for several historical and economical reasons. The implementation of such programs is likely to be beneficial at different levels, including the reduction of the number of adverse events and improvement of health-related quality of life. The main objective of the study is to determine the long-term benefit of a nurse-led prevention program among patients starting long-term corticosteroids therapy, compared to routine care.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 or older * Initiation of corticosteroids within 30 days prior to inclusion * Estimated cumulative dosage of corticosteroids ≥ 2000 mg * Affiliated member of the social security system Exclusion Criteria: * Patients unable to give consent or unable to understand the protocol * A patient who is not 'or is no longer' able to communicate remotely by telephone could not 'or no longer' be included in the study. * Patients under guardianship * Previous exposure to long-term corticosteroids * Prescription of corticosteroids for the management of malignant neoplasms * Severe chronic renal failure with clearance of creatinine \< 30 ml/min. * History of organ transplantation * Pregnant or breastfeeding women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04909606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Long Term Corticosteroid Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04909606 currently recruiting?
Yes, NCT04909606 is actively recruiting participants. Contact the research team at solen.nicol@chu-brest.fr for enrollment information.
Where is the NCT04909606 trial being conducted?
This trial is being conducted at Brest, France, La Rochelle, France, Le Mans, France, Le Puy-en-Velay, France and 1 additional location.
Who is sponsoring the NCT04909606 clinical trial?
NCT04909606 is sponsored by University Hospital, Brest. The trial plans to enroll 191 participants.